Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2026-01-01 @ 10:23 PM
Study NCT ID:
NCT04334057
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2020-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2020-04-02', 'studyFirstSubmitQcDate': '2020-04-02', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse reactions (ARs) reported during the observation period', 'timeFrame': 'From baseline (week 0) to end of study (week 104)', 'description': 'Count'}], 'secondaryOutcomes': [{'measure': 'Number of serious adverse events (SAEs) reported during the observation period', 'timeFrame': 'From baseline (week 0) to end of study (week 104)', 'description': 'Count'}, {'measure': 'Number of serious adverse reactions (SARs) reported during the observation period', 'timeFrame': 'From baseline (week 0) to end of study (week 104)', 'description': 'Count'}, {'measure': 'Number of patients who have confirmed inhibitory antibodies against FVIII during the observation period', 'timeFrame': 'From baseline (week 0) to end of study (week 104)', 'description': 'Count'}, {'measure': 'Number of bleeding episodes requiring treatment for patients using Esperoct® during the observation period assessed by annual bleeding rate (ABR)', 'timeFrame': 'From baseline (week 0) to end of study (week 104)', 'description': 'Count'}, {'measure': 'Evaluation of the haemostatic response of Esperoct® measured as number of successes for treatment requiring bleeds', 'timeFrame': 'From baseline (week 0) to end of study (week 104)', 'description': 'Count, assessed based on a four-point scale (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure'}, {'measure': 'Evaluation of the haemostatic response of Esperoct® measured as number of successes in treatment of bleeds in perioperative management during surgical procedures', 'timeFrame': 'From baseline (week 0) to end of study (week 104)', 'description': 'Count, assessed as success/failure based on a four-point scale for haemostatic response (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Haemophilia A']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and effectiveness of Esperoct® for long-term routine use in patients with Haemophilia A. Participants will get Esperoct® as prescribed by their doctor. The study will last for about 2 years for each participant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Haemophilia A patients in routine clinical practice in Japan', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).\n* The decision to initiate treatment with commercially available Esperoct® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.\n* Diagnosis of haemophilia A in males or females, no age limitation.\n* New patients who have not previously been exposed to Esperoct®.\n\nExclusion Criteria:\n\n* Previous participation in this study. Participation is defined as having given informed consent in this study.\n* Known or suspected hypersensitivity to study product or related products.\n* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.'}, 'identificationModule': {'nctId': 'NCT04334057', 'briefTitle': 'Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®. A Multi-centre, Prospective, Observational, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Effectiveness of Esperoct® in Haemophilia A Patients Under Routine Clinical Practice Conditions in Japan', 'orgStudyIdInfo': {'id': 'NN7088-4484'}, 'secondaryIdInfos': [{'id': 'U1111-1216-4626', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with haemophilia A', 'description': 'New patients who have not previously been exposed to Esperoct® (Turoctocog alfa pegol or N8-GP in clinical trials) are eligible for this study.', 'interventionNames': ['Drug: Turoctocog alfa pegol']}], 'interventions': [{'name': 'Turoctocog alfa pegol', 'type': 'DRUG', 'description': 'Patients will be treated with commercially available Esperoct® according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Esperoct® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.', 'armGroupLabels': ['Patients with haemophilia A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '830-0011', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Kurume University Hospital, Pediatrics', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '501-1194', 'city': 'Gifu', 'country': 'Japan', 'facility': 'Gifu University Hospital', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '350 0495', 'city': 'Iruma-gun, Saitama', 'country': 'Japan', 'facility': 'Saitama Medical University Hospital, Pediatrics', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '602-8566', 'city': 'Kamigyo-ku, Kyoto', 'country': 'Japan', 'facility': 'University Hospital Kyoto Prefectual University of Medicine'}, {'zip': '216-8511', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'St. Marianna University School of Medicine Hospital_Pediatrics', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '216-8511', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'St. Marianna University School of Medicine Hospital', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '634-8522', 'city': 'Nara', 'country': 'Japan', 'facility': 'Nara Medical University Hospital_Pediatrics', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'zip': '901-1193', 'city': 'Okinawa', 'country': 'Japan', 'facility': "Nanbu Medical Center & Children's Medical Center", 'geoPoint': {'lat': 26.33583, 'lon': 127.80139}}, {'zip': '350-0225', 'city': 'Saitama', 'country': 'Japan', 'facility': "Shibuya Children's Clinic, Department of Pediatric", 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '520-2145', 'city': 'Shiga', 'country': 'Japan', 'facility': 'Lake Children Clinic', 'geoPoint': {'lat': 36.02247, 'lon': 138.13005}}, {'zip': '420-8660', 'city': 'Shizuoka', 'country': 'Japan', 'facility': "Shizuoka Children's Hospital, Hematology-Oncology", 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': '420-8660', 'city': 'Shizuoka', 'country': 'Japan', 'facility': "Shizuoka Children's Hospital", 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': '113-8603', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Nippon Medical School Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '160-0023', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Medical Univ. Hospital_Laboratory Medicine', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '160-0023', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Medical Univ. Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '167-0035', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Ogikubo Hospital_Tokyo', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '998-8501', 'city': 'Yamagata', 'country': 'Japan', 'facility': 'Nihonkai Sogo Hospital_Internal Medicine', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}, {'zip': '998-8501', 'city': 'Yamagata', 'country': 'Japan', 'facility': 'Nihonkai Sogo Hospital', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}, {'zip': '241-0811', 'city': 'Yokohama-shi, Kanagawa', 'country': 'Japan', 'facility': 'St. Marianna Univ., Yokohama City Seibu HP, Pediatrics Dept,'}], 'overallOfficials': [{'name': 'Clinical Reporting Anchor & Disclosure (1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}